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Section Free  - Quick Takes

04. Metformin for the Prevention of Clozapine-Induced Weight Gain: A Retrospective Naturalistic Cohort Study

Published on September 1, 2022 Certification expiration date: September 1, 2028

James Phelps, M.D.

Research Editor - Psychopharmacology Institute

Key Points

  • Metformin is clearly protective against weight gain for new users of second-generation antipsychotics, but one must consider starting it very early, almost concomitantly.
  • Among patients with bipolar depression, those who experienced reversal of their insulin resistance with metformin were likely to experience a substantial improvement in mood and anxiety (d=1.5 and 1.0, respectively, vs nonreversal).

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Would you prescribe metformin or let primary care handle that? Here are several articles on metformin, which together put more pressure on us to either prescribe it or assure that it’s being aggressively considered and managed by another team member.

Hi! Jim Phelps here for the Psychopharmacology Institute. Officially, this Quick Take is about metformin for patients taking clozapine, but let’s look at metformin more broadly. You wouldn’t likely be surprised to hear that among patients starting clozapine, those who were also given metformin or were already on it had less weight gain than the clozapine-alone group. But you might not expect the numbers at 1 year. No weight gain at all in the clozapine-metformin group vs a 4.7 kg increase for clozapine alone.

A 2016 meta-analysis found that metformin was more effective in preventing antipsychotic-induced weight gain in first-episode patients than in patients who’d already gained weight, and that weight gain can happen fast. One study found that the average weight gain in the first 3 months of antipsychotic treatment was 3.5 kg. So, if you’re going to prescribe metformin, the data suggest you should do it very early, maybe even starting it almost concomitantly with antipsychotics that are also notorious for weight gain like olanzapine, risperidone, and quetiapine. But many psychiatrists are understandably hesitant to prescribe metformin. It’s a scope of practice issue and a relationship with primary care issue. And of course, there are nonmedication alternatives for weight control and those should be vigorously used with good motivational interviewing.

Well, here’s another prod toward getting your weight management act together—the TRIO-BD study. This is a randomized trial of metformin in treatment-resistant bipolar depression. It’s small and it needs replication, but the implications are huge. This study was led by Dr. Cynthia Culkin, a former primary care physician who later trained in psychiatry. She and her colleagues’ hypothesis was that insulin resistance contributes to treatment resistance in bipolar depression. All 45 research participants in this study had insulin resistance as defined by fasting glucose and insulin levels, and the authors compared outcomes for patients who converted, who no longer met criteria for insulin resistance, vs nonconverters. Half the patients randomized to metformin converted vs 1 patient on placebo.

Among the converters, depression scores on the Montgomery-Asberg Depression Rating Scale or the MADRS were significantly lower at 6 months, with an effect size of 1.5. That’s huge. Interestingly, anxiety scores on the Hamilton Anxiety Scale were also significantly lower for the converters, with an effect size of 1.0.

Now, this is a preliminary trial. There were only 11 converters. Nevertheless, I hope it’s making you think about how to manage weight gain with your patients. Imagine that if by inducing insulin resistance, we also induce treatment resistance, at least in bipolar depression. That’s an iatrogenic disaster.

One more finding that might be reassuring as you contemplate using metformin for patients at risk of metabolic syndrome. In Dr. Culkin’s study, loose stool was the most common side effect in 40% of the metformin group. This was also present in 32% of the placebo group, which was not statistically different from the metformin group—nor was any other side effect, including nausea or vomiting, statistically more common in the metformin group.

For more on this, perhaps it’s time to review the prescribing information on metformin if you’re not already routinely using it.

Abstract

Objective: Clozapine is presently the sole antipsychotic with an indication for treatment-resistant Schizophrenia, but is associated with significant weight gain and other metabolic aberrations. This retrospective chart review aimed to evaluate the effectiveness of adjunctive metformin in preventing clozapine-induced weight gain.

Methods: We conducted a retrospective chart review of patients newly initiated on clozapine at the Centre for Addiction and Mental Health in Canada, from November 2014 to April 2021. Our primary outcome was body weight at 6 and 12 months after clozapine initiation. Other metabolic parameters served as secondary outcomes.

Results: Among 396 patients (males: 71.5%, mean age: 42.8 years) initiated on clozapine, 69 were on metformin or prescribed it ≤3 months after clozapine initiation. The clozapine+metformin group demonstrated less weight gain compared with the clozapine-only group at 6 months (clozapine+metformin: -0.15 kg [SE = 1.08] vs. clozapine-only: 2.99 kg, SE = 0.54) and 12 months after clozapine initiation (clozapine+metformin: -0.67 kg, SE = 1.22 vs. clozapine-only: 4.72 kg, SE = 0.67). Adaptive changes were also observed for fasting glucose (F = 3.10, p = 0.046) and triglycerides (F = 8.56, p < 0.001) in the clozapine+metformin group compared with clozapine only.

Conclusion: In this large retrospective naturalistic cohort study, co-prescription of clozapine and metformin was associated with less weight gain and related metabolic dysfunction at 6 and 12 months after initiation versus clozapine alone. These findings provide evidence for the effectiveness of metformin in preventing clozapine-induced weight gain; larger randomized controlled trials are needed to confirm these results.

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Reference

Stogios, N., Maksyutynska, K., Navagnanavel, J., Sanches, M., Powell, V., Gerretsen, P., Graff-Guerrero, A., Chintoh, A. F., Foussias, G., Remington, G., Hahn, M. K., & Agarwal, S. M. (2022).

Metformin for the prevention of clozapine-induced weight gain: A retrospective naturalistic cohort study.

Acta Psychiatrica Scandinavica,

10.1111/acps.13462. Advance online publication.

Table of Contents

Learning Objectives:

After completing this activity, the learner will be able to:

  1. Examine proposed clinical guidelines for the management of clozapine risks during medication titration.
  2. Consider the frequency of anticholinergic misuse relative to other commonly used substances.
  3. Examine rehospitalization rates for patients with first-episode schizophrenia diagnoses and possible implications for antipsychotic dosing for relapse prevention.
  4. Review the impact of metformin in psychiatric patients across 3 studies for the prevention of clozapine-induced weight gain.
  5. Examine findings in a recent systematic umbrella review tackling the serotonin hypothesis of depression.

Original Release Date: September 1, 2022

Review and Re-release Date: September 1, 2025

Expiration Date: September 1, 2028

Expert: James Phelps, M.D.

Medical Editor: Melissa Mariano, M.D.

Relevant Financial Disclosures: 

None of the faculty, planners, and reviewers for this educational activity have relevant financial relationships to disclose during the last 24 months with ineligible companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

Contact Information: For questions regarding the content or access to this activity, contact us at support@psychopharmacologyinstitute.com

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Participants must complete the activity online during the valid credit period that is noted above.

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  1. View the required educational content provided on this course page.
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This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education through the joint providership of Medical Academy LLC and the Psychopharmacology Institute. Medical Academy is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation Statement

Medical Academy designates this enduring activity for a maximum of 0.5 AMA PRA Category 1 credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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